QA Compliance Lead - Afternoons
Bimeda•Pomona, CA
•Onsite
About The Position
The QA Compliance Lead is the senior-most QA Compliance resource supporting manufacturing operations and serves as the primary day-to-day quality lead. This role ensures consistent execution of cGMP compliance activities, including batch record review, deviation investigations, CAPA oversight, and audit readiness. The Lead acts as a key partner to the QA Manager by driving quality processes, supporting regulatory readiness, and providing guidance to QA Compliance Associates.
Requirements
- 5–7 years in pharmaceutical QA / GMP environment
- Strong experience in: - Batch record review & product release - Deviation investigations & CAPA systems - Audit support (FDA/customer)
- Demonstrated ability to work independently and make quality-based decisions
- Strong technical writing and documentation skills
- Proven ability to coach others without formal authority
Responsibilities
- Own day-to-day QA compliance activities across manufacturing, ensuring timely batch review and product release in accordance with GMP standards.
- QA oversight of manufacturing, including label control and issuance and in-process inspections.
- Lead deviation investigations, OOS events, and non-conformances, including root cause analysis and CAPA development.
- Review and approve QA documentation (batch records, deviations, CAPAs) prior to QA Manager escalation where required.
- Serve as primary QA contact on the floor, providing real-time guidance to Associates, operators, and supervisors.
- Conduct and support internal audits to ensure adherence to SOPs, cGMP, and regulatory requirements.
- Support regulatory inspections and customer audits, including preparation, hosting support, and follow-up actions.
- Monitor QA systems and quality trends, escalating risks and recommending improvements.
- Support SOP and document updates to maintain compliance and operational efficiency.
- Coach and mentor QA Compliance Associates on investigations, documentation, and GMP expectations.
- Partner cross-functionally with Operations, QC, and other teams to drive a culture of quality and compliance.
Benefits
- Health Insurance (medical, dental, vision)
- 401(k) plan for retirement savings
- Paid time off (vacation, sick leave, holidays)
- Life insurance
- Employee assistance program
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
